Details for New Drug Application (NDA): 214505
NDA 214505 describes MITOMYCIN, which is a drug marketed by Accord Hlthcare, Adaptis, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, and Meitheal, and is included in twelve NDAs. It is available from eleven suppliers. Additional details are available on the MITOMYCIN profile page.
The generic ingredient in MITOMYCIN is mitomycin. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
The generic ingredient in MITOMYCIN is mitomycin. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
Pharmacology for NDA: 214505
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 214505
Suppliers and Packaging for NDA: 214505
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 214505 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-137 | 71288-137-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-137-20) / 10 mL in 1 VIAL, SINGLE-DOSE |
| MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 214505 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-138 | 71288-138-50 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-138-50) / 40 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/VIAL | ||||
| Approval Date: | Sep 8, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
| Approval Date: | Sep 8, 2022 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
